Reported Jul 12, 2017 · Completed
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to…
CardioTek BV
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CardioTek BV · Amerikalaan 70 · Maastricht-Airport, N/A · N/A
Is this the product you have?
- CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
- Lot codes and dates
- All EP-Tracer -FSCA-identifier (2017-04-06)
- Amount recalled
- 8 units US
Where it was sold
Why it was recalled
Software bug which allows parameters to be changed unintentionally during use.
This product could cause temporary or reversible health problems — stop using it.
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